Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0487-0111 A · 3 trials · 2 indications
Number of events
Measured as hours picograms per milliliter (h\*pg/mL).
Measured as hours picograms per milliliter (h\*pg/mL).
Number of events
| Arm | Type | Description |
|---|---|---|
| Cohort A1 | EXPERIMENTAL | Cohort A1 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 1 of active treatment and 3 participants randomised to receive placebo. |
| Cohort A2 | EXPERIMENTAL | Cohort A2 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 2 of active treatment and 3 participants randomised to receive placebo. |
| Cohort A3 | EXPERIMENTAL | Cohort A3 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 3 of active treatment and 3 participants randomised to receive placebo. |
| NNC0487-0111 | EXPERIMENTAL | Participants will receive oral dosing of NNC0487-0111 and gradually will escalate from dose 1 to dose 2. The oral NNC0487-0111 treatment will be followed by s.c. NNC0487-0111 treatment with dose escalating from dose 3 to dose 4. |
| Part A: Single ascending dose (SAD) | EXPERIMENTAL | Participants will receive a single dose of any of the six different dose levels (1, 3, 6, 12, 25 and 50 milligrams (mg)) of NNC0487-0111 A or matching placebo in a sequential manner with the dose increasing between cohorts. |
| Part B: Multiple ascending dose (MAD) | EXPERIMENTAL | Participants will receive NNC0487-0111 once daily for 10 days at any of the five different dose levels (3, 6, 12, 25 and 50 milligrams (mg)) of NNC0487-0111 A or matching placebo in a sequential manner with the dose increasing between cohorts. |
| Part C | EXPERIMENTAL | Participants will receive NNC0487-0111 A or matching placebo once-daily for 12 weeks: 3 or 6 mg for weeks 1-2, 6 or 12 mg for weeks 3-4, 12 or 25 mg for weeks 5-6, 25 or 50 mg for weeks 7-8, 25 or 50 mg for weeks 9-10 and 50 or 2\*50 mg for weeks 11-12. |
| Part D | EXPERIMENTAL | Participants will receive NNC0487-0111 B or matching placebo once-daily for 12 weeks: 3 or 6 mg for weeks 1-2, 6 or 12 mg for weeks 3-4, 12 or 25 mg for weeks 5-6, 25 or 50 mg for weeks 7-8, 25 or 50 mg for weeks 9-10 and 50 or 2\*50 mg for weeks 11-12. |
| Name | Type | Description |
|---|---|---|
| NNC0487-0111 A | DRUG | Participants will receive single dose (level 1, level 2, level 3) injection of NNC0487-0111 A subcutaneoulsy. |
| Placebo A | DRUG | Participants will receive single dose (level 1, level 2, level 3) injection of placebo A subcutaneoulsy. |
| NNC0487-0111 C | DRUG | NNC0487-0111 C will be taken orally. |
| Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) | DRUG | Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) will be taken orally. |
| Acetaminophen - 500 mg/15 ml | DRUG | Acetaminophen - 500 mg/15 ml will be taken orally. |
| NNC0487-0111 B | DRUG | Participants will receive NNC0487-0111 B tablet once daily. |
| Placebo B (NNC0487-0111 B) | OTHER | Participants will receive placebo matched to NNC0487-0111 B tablet once daily. |
| Placebo A (NNC0487-0111 A) | OTHER | Participants will receive placebo matched to NNC0487-0111 A tablet once daily. |
Inclusion Criteria: 1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. 2. Male Chinese participants, age 18-55 years (both inclusive) at...
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NNC0487-0111 A is an investigational small molecule being studied for the treatment of overweight and obesity. It is in Phase 1 clinical development by Novo Nordisk A/S. The drug is administered by subcutaneous injection and is being evaluated in people with overweight or obesity.
NNC0487-0111 A is being developed by Novo Nordisk A/S, a biopharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting Phase 1 clinical trials to evaluate the drug's effects in people with overweight or obesity.
NNC0487-0111 A is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, and the drug is being studied for the treatment of overweight and obesity.
NNC0487-0111 A has been studied in two completed Phase 1 clinical trials. One trial (NCT05369390) enrolled 144 participants with obesity in the United States. Another trial (NCT06461039) enrolled 43 women in Canada to study how the drug works with birth control pills and affects stomach emptying.
NNC0487-0111 A is the name used in clinical trial records for this investigational drug. It is also referred to simply as NNC0487-0111 in some study titles. Both names refer to the same compound being developed by Novo Nordisk for overweight and obesity.
NNC0487-0111 A is administered by subcutaneous injection, meaning it is injected under the skin. This route of administration is being tested in clinical trials involving participants with overweight or obesity, including studies conducted in the United States, Canada, and China.